The effect of metformin on the incidence of preeclampsia in pregnant women with low pregnancy-associated plasma protein A
Design
The current clinical trial study has a control group, with parallel groups, single-blind, randomized (using block randomization), phase 3 on 80 patients.
Settings and conduct
In this single-blind randomization clinical trial, pregnant women with low pregnancy-associated plasma protein A referring to Ayatollah Taleghani Hospital in Arak will be divided into two equal intervention and control groups by means of block randomization. In the intervention group, patients will receive metformin 500 mg oral tablets daily, and in the control group, they will receive placebo tablets daily. In this study, the patients are blinded by the identical appearance of the tablets. Finally, the two groups are compared in terms of outcomes.
Participants/Inclusion and exclusion criteria
Conditions for inclusion in the study: Pregnant mothers with low pregnancy-related plasma protein A referred to kousar Clinic, Normal arterial Doppler ultrasound; Age 18-50 years; Consent to participate in the study.
Conditions for not entering the study: History of intrauterine growth restriction or preeclampsia, gestational hypertension or pregnancy complications in previous pregnancies; History of congenital disease; History of liver or kidney failure.
Intervention groups
Intervention group: Patients in this group will receive metformin 500 mg oral tablets of Exir pharmaceutical company once a day until the end of pregnancy. Control group: Patients in this group will receive an oral tablet similar to metformin made of starch daily until the end of pregnancy.
Main outcome variables
functional liver enzymes; systolic and diastolic blood pressure; proteinuria; Preterm delivery; low birth weight; Type of delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191104045328N14
Registration date:2022-12-26, 1401/10/05
Registration timing:prospective
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-04-09, 1402/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of metformin on the incidence of preeclampsia in pregnant women with low pregnancy-associated plasma protein A
Public title
The effect of metformin on reducing preeclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers with low pregnancy-related plasma protein A referred to kousar Clinic
Normal arterial Doppler ultrasound
Age 18-50 years
Consent to participate in the study
Exclusion criteria:
History of intrauterine growth restriction or preeclampsia, gestational hypertension or pregnancy complications in previous pregnancies
History of congenital disease
History of liver or kidney failure
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced.
Blinding (investigator's opinion)
Single blinded
Blinding description
This trial is single-blind. For this purpose, one group will receive metformin tablets and the other group will receive a starch tablet similar to metformin, and the mothers participating in the study are not aware of the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-06-13, 1401/03/23
Ethics committee reference number
IR.ARAKMU.REC.1401.138
Health conditions studied
1
Description of health condition studied
Pre-eclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Functional liver enzymes
Timepoint
in the 14th, 28th, 32nd weeks of pregnancy and at the time of delivery
Method of measurement
laboratory test
2
Description
Systolic and diastolic blood pressure
Timepoint
in the 14th, 28th, 32nd weeks of pregnancy and at the time of delivery
Method of measurement
Mercury sphygmomanometer
3
Description
proteinuria
Timepoint
in the 14th, 28th, 32nd weeks of pregnancy and at the time of delivery
Method of measurement
Urinalysis test
4
Description
Preterm delivery
Timepoint
Delivery between 20 and 37 weeks
Method of measurement
Delivery
5
Description
Low birth weight
Timepoint
Birth weight less than 2500 grams
Method of measurement
scales
6
Description
Type of delivery
Timepoint
How the baby is born
Method of measurement
Cesarean-vaginal
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will receive metformin 500 mg oral tablets of Exir pharmaceutical company once a day until the end of pregnancy.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive an oral tablet similar to metformin made of starch daily until the end of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital, Arak
Full name of responsible person
Dr. Maryam Maktabi
Street address
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 912 195 1402
Email
It-taleghani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mehdi Salehi
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3532
Email
salehi58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Maryam Maktabi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Email
Dr.maryam.maktabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Azam Muslimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
Azammoslemi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Arzoo Afzal Shahidi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3532
Email
15.a.shahidi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will be from 2023/4/20 to 2026/4/20 for 3 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.
From where data/document is obtainable
University researchers and university professors, after contacting the respective professor by message or email, can request the utilization and use of data from Dr. Maryam Maktabi and then Dr. Seyedeh Arzoo Afzal Shahidi, respectively.
Dr. Maryam Maktabi: Phone: 09121951402 Email: Dr.maryam.maktabi@gmail.com Address: Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
Dr. Seyedeh Arzoo Afzal Shahidi: Phone: 09153221459 Email: 15.a.shahidi@gmail.com Address: Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.